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Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation (MITRA-FR)

Primary Purpose

Cardiovascular Diseases

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Percutaneous MitraClip Device Implantation
control
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases focused on measuring Heart Valve Diseases, Heart failure, Heart diseases, Mitral valve insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18 years old
  • Severe secondary mitral regurgitation characterised, according to the European guidelines and recommendations, by a regurgitant volume>30 mL/beat or an effective regurgitant orifice>20 mm².
  • New York heart Association Class≥ II.
  • Left ventricular ejection fraction between 15% and 40%
  • Minimum of 1 hospitalization for heart failure within 12 months preceding randomization
  • Optimal standard of care therapy for heart failure according to investigator.
  • Not eligible for a mitral surgery intervention according to the Heart Team.
  • Willingness to participate in the study and signed written informed consent
  • Affiliation to a health insurance system or a similar system

Exclusion Criteria:

  • Eligible for a mitral surgery intervention according to the Heart Team.
  • Primary mitral regurgitation.
  • Myocardial infarction or coronary bypass grafting surgery within three months prior to randomization.
  • Cardiac resynchronization therapy within three months prior to randomization.
  • Cardioversion within three months prior to randomization
  • Transcatheter aortic valve implantation within three months prior to randomization
  • Need for any cardiovascular surgery (including registration on cardiac transplant list).
  • Coronary angioplasty within one month prior to randomization.
  • Previous surgical mitral valve repair.
  • Renal replacement therapy.
  • Active infection requiring current antibiotic therapy.
  • Severe hepatic insufficiency.
  • Stroke within three months prior to randomization.
  • Concurrent medical condition with a life expectancy of less than 12 months.
  • Uncontrolled arterial hypertension.
  • Hypersensitivity to nitinol.
  • Participation to another trial.
  • Pregnancy.
  • No affiliation to a health insurance system.
  • Legal protection measure (guardianship or curatorship)

Sites / Locations

  • CHU d'Angers
  • Chu de Besancon
  • Chu de Bordeaux
  • CHRU La Cavale Blanche
  • Groupement Hospitalier Est
  • CHU Caen
  • Hôpital Gabriel Montpied
  • APHP Hôpital Henri Mondor
  • CHU de Grenoble
  • Hôpital privé de Parly 2
  • Centre Chirurgical Marie Lannelongue
  • Chu de Lille
  • Hôpital privé le Bois
  • Hôpital Saint-Joseph
  • Hopital de La Timone
  • Hôpital privé Clairval
  • Institut Hospitalier Jacques Cartier
  • CH Annecy Genevois
  • Chu de Montpellier
  • Clinique Du Millenaire
  • Chu de Nancy
  • Chu de Nantes
  • Centre chirurgicale Ambroise Paré
  • Hôpital Pasteur
  • Groupe Hospitalier La Salpétrière
  • Institut Mutualiste Montsouris
  • Hôpital Européen Georges Pompidou
  • Aphp Hopital Bichat
  • CHRU La Milétrie
  • Chu de Rennes
  • CHU Rouen
  • Centre Cardiologique du Nord
  • Institut Arnault Tzanck
  • Hôpital Nord
  • Chu de Strasbourg
  • Clinique Pasteur
  • Chu de Toulouse
  • CHRU de Tours
  • Clinique Cardiologique Saint Gatien
  • Clinique du Tonkin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

MitraClip Device

Control

Arm Description

Subjects randomized to the MitraClip Device group will undergo the MitraClip procedure in addition to optimal standard medical therapy.

Patients randomized to the Control group will receive optimal therapy alone

Outcomes

Primary Outcome Measures

All-cause mortality and unplanned hospitalizations for heart failure

Secondary Outcome Measures

All-cause mortality, cardiac mortality
Survival with no major cardiovascular events
Serious Adverse Events
Any serious adverse events cardiovascular or not occurring within each group.
Change in Quality of Life score as measured by the European Quality of Life-5 Dimensions instrument.
Change in functional evaluation
Change in echocardiographic evaluation between baseline at 6, 12 and 24 months.
Change in biomarkers (BNP levels, creatinine) at 6 months and 12 months
Cost-effectiveness of each strategy at 12 months
Cost-effectiveness of each therapeutic strategy will be assessed by the evaluation of medical costs linked to the pathology (hospitalizations, consultations, and external medical costs (biology, radiology, medications) and compared in the 2 groups during the first 12 months of follow up.

Full Information

First Posted
August 8, 2013
Last Updated
July 9, 2018
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01920698
Brief Title
Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation
Acronym
MITRA-FR
Official Title
Multicentre Randomized Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this trial is to compare the safety, the efficacy and the cost-effectiveness of 2 therapeutic strategies (optimal standard of care therapy alone versus percutaneous MitraClip procedure and optimal standard of care therapy) in patients with severe secondary mitral regurgitation. This trial is a French, multicenter and randomized trial. Patients enrolled will be clinically followed for 2 years (phone call at 1 month, clinical visit at 6 months, 12 months and 24 months).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases
Keywords
Heart Valve Diseases, Heart failure, Heart diseases, Mitral valve insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MitraClip Device
Arm Type
Experimental
Arm Description
Subjects randomized to the MitraClip Device group will undergo the MitraClip procedure in addition to optimal standard medical therapy.
Arm Title
Control
Arm Type
Other
Arm Description
Patients randomized to the Control group will receive optimal therapy alone
Intervention Type
Device
Intervention Name(s)
Percutaneous MitraClip Device Implantation
Intervention Description
MitraClip System includes a MitraClip device, a steerable guide catheter and a MitraClip delivery system
Intervention Type
Other
Intervention Name(s)
control
Other Intervention Name(s)
Patients randomized to the Control Group will receive optimal medical therapy alone
Primary Outcome Measure Information:
Title
All-cause mortality and unplanned hospitalizations for heart failure
Time Frame
1 year
Secondary Outcome Measure Information:
Title
All-cause mortality, cardiac mortality
Time Frame
30 days, 6 months, 12 months, and 24 months.
Title
Survival with no major cardiovascular events
Time Frame
30 days, 6 months, 12 months, and 24 months.
Title
Serious Adverse Events
Description
Any serious adverse events cardiovascular or not occurring within each group.
Time Frame
30 days, 6 months, 12 months and 24 months.
Title
Change in Quality of Life score as measured by the European Quality of Life-5 Dimensions instrument.
Time Frame
6 months and 12 months
Title
Change in functional evaluation
Time Frame
12 months
Title
Change in echocardiographic evaluation between baseline at 6, 12 and 24 months.
Time Frame
6 months, 12 months and 24 months
Title
Change in biomarkers (BNP levels, creatinine) at 6 months and 12 months
Time Frame
6 months and 12 months
Title
Cost-effectiveness of each strategy at 12 months
Description
Cost-effectiveness of each therapeutic strategy will be assessed by the evaluation of medical costs linked to the pathology (hospitalizations, consultations, and external medical costs (biology, radiology, medications) and compared in the 2 groups during the first 12 months of follow up.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years old Severe secondary mitral regurgitation characterised, according to the European guidelines and recommendations, by a regurgitant volume>30 mL/beat or an effective regurgitant orifice>20 mm². New York heart Association Class≥ II. Left ventricular ejection fraction between 15% and 40% Minimum of 1 hospitalization for heart failure within 12 months preceding randomization Optimal standard of care therapy for heart failure according to investigator. Not eligible for a mitral surgery intervention according to the Heart Team. Willingness to participate in the study and signed written informed consent Affiliation to a health insurance system or a similar system Exclusion Criteria: Eligible for a mitral surgery intervention according to the Heart Team. Primary mitral regurgitation. Myocardial infarction or coronary bypass grafting surgery within three months prior to randomization. Cardiac resynchronization therapy within three months prior to randomization. Cardioversion within three months prior to randomization Transcatheter aortic valve implantation within three months prior to randomization Need for any cardiovascular surgery (including registration on cardiac transplant list). Coronary angioplasty within one month prior to randomization. Previous surgical mitral valve repair. Renal replacement therapy. Active infection requiring current antibiotic therapy. Severe hepatic insufficiency. Stroke within three months prior to randomization. Concurrent medical condition with a life expectancy of less than 12 months. Uncontrolled arterial hypertension. Hypersensitivity to nitinol. Participation to another trial. Pregnancy. No affiliation to a health insurance system. Legal protection measure (guardianship or curatorship)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JEAN FRANCOIS OBADIA, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Chu de Besancon
City
Besancon
Country
France
Facility Name
Chu de Bordeaux
City
Bordeaux
Country
France
Facility Name
CHRU La Cavale Blanche
City
Brest
Country
France
Facility Name
Groupement Hospitalier Est
City
Bron
Country
France
Facility Name
CHU Caen
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Hôpital Gabriel Montpied
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
APHP Hôpital Henri Mondor
City
Creteil
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38700
Country
France
Facility Name
Hôpital privé de Parly 2
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Facility Name
Centre Chirurgical Marie Lannelongue
City
Le Plessis Robinson
Country
France
Facility Name
Chu de Lille
City
Lille
Country
France
Facility Name
Hôpital privé le Bois
City
Lille
Country
France
Facility Name
Hôpital Saint-Joseph
City
Marseille
ZIP/Postal Code
13285
Country
France
Facility Name
Hopital de La Timone
City
Marseille
Country
France
Facility Name
Hôpital privé Clairval
City
Marseille
Country
France
Facility Name
Institut Hospitalier Jacques Cartier
City
Massy
Country
France
Facility Name
CH Annecy Genevois
City
Metz-Tessy
ZIP/Postal Code
74370
Country
France
Facility Name
Chu de Montpellier
City
Montpellier
Country
France
Facility Name
Clinique Du Millenaire
City
Montpellier
Country
France
Facility Name
Chu de Nancy
City
Nancy
Country
France
Facility Name
Chu de Nantes
City
Nantes
Country
France
Facility Name
Centre chirurgicale Ambroise Paré
City
Neuilly Sur Seine
ZIP/Postal Code
92200
Country
France
Facility Name
Hôpital Pasteur
City
Nice
ZIP/Postal Code
06001
Country
France
Facility Name
Groupe Hospitalier La Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Aphp Hopital Bichat
City
Paris
Country
France
Facility Name
CHRU La Milétrie
City
Poitiers
Country
France
Facility Name
Chu de Rennes
City
Rennes
Country
France
Facility Name
CHU Rouen
City
Rouen
Country
France
Facility Name
Centre Cardiologique du Nord
City
Saint Denis
Country
France
Facility Name
Institut Arnault Tzanck
City
Saint Laurent Du Var
Country
France
Facility Name
Hôpital Nord
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
Facility Name
Chu de Strasbourg
City
Strasbourg
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
Chu de Toulouse
City
Toulouse
Country
France
Facility Name
CHRU de Tours
City
Tours
Country
France
Facility Name
Clinique Cardiologique Saint Gatien
City
Tours
Country
France
Facility Name
Clinique du Tonkin
City
Villeurbanne
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33347327
Citation
Iung B, Messika-Zeitoun D, Boutitie F, Trochu JN, Armoiry X, Maucort-Boulch D, Obadia JF, Vahanian A. Characteristics and Outcome of COAPT-Eligible Patients in the MITRA-FR Trial. Circulation. 2020 Dec 22;142(25):2482-2484. doi: 10.1161/CIRCULATIONAHA.120.049743. Epub 2020 Dec 21. No abstract available.
Results Reference
derived
PubMed Identifier
32950444
Citation
Messika-Zeitoun D, Iung B, Armoiry X, Trochu JN, Donal E, Habib G, Brochet E, Thibault H, Piriou N, Cormier B, Tribouilloy C, Guerin P, Lefevre T, Maucort-Boulch D, Vahanian A, Boutitie F, Obadia JF. Impact of Mitral Regurgitation Severity and Left Ventricular Remodeling on Outcome After MitraClip Implantation: Results From the Mitra-FR Trial. JACC Cardiovasc Imaging. 2021 Apr;14(4):742-752. doi: 10.1016/j.jcmg.2020.07.021. Epub 2020 Sep 16.
Results Reference
derived
PubMed Identifier
31476260
Citation
Iung B, Armoiry X, Vahanian A, Boutitie F, Mewton N, Trochu JN, Lefevre T, Messika-Zeitoun D, Guerin P, Cormier B, Brochet E, Thibault H, Himbert D, Thivolet S, Leurent G, Bonnet G, Donal E, Piriou N, Piot C, Habib G, Rouleau F, Carrie D, Nejjari M, Ohlmann P, Saint Etienne C, Leroux L, Gilard M, Samson G, Rioufol G, Maucort-Boulch D, Obadia JF; MITRA-FR Investigators. Percutaneous repair or medical treatment for secondary mitral regurgitation: outcomes at 2 years. Eur J Heart Fail. 2019 Dec;21(12):1619-1627. doi: 10.1002/ejhf.1616. Epub 2019 Nov 18.
Results Reference
derived
PubMed Identifier
30145927
Citation
Obadia JF, Messika-Zeitoun D, Leurent G, Iung B, Bonnet G, Piriou N, Lefevre T, Piot C, Rouleau F, Carrie D, Nejjari M, Ohlmann P, Leclercq F, Saint Etienne C, Teiger E, Leroux L, Karam N, Michel N, Gilard M, Donal E, Trochu JN, Cormier B, Armoiry X, Boutitie F, Maucort-Boulch D, Barnel C, Samson G, Guerin P, Vahanian A, Mewton N; MITRA-FR Investigators. Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation. N Engl J Med. 2018 Dec 13;379(24):2297-2306. doi: 10.1056/NEJMoa1805374. Epub 2018 Aug 27.
Results Reference
derived

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Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation

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